UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062249 |
|---|---|
| Receipt number | R000071229 |
| Scientific Title | Impact of non-dilation techniques and other clinical and procedural factors on the outcomes of endoscopic ultrasound-guided biliary drainage. |
| Date of disclosure of the study information | 2026/07/15 |
| Last modified on | 2026/07/15 16:44:15 |
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Basic information
Public title
Impact of non-dilation techniques and other clinical and procedural factors on the outcomes of endoscopic ultrasound-guided biliary drainage.
Acronym
Impact of non-dilation techniques and other clinical and procedural factors on the outcomes of endoscopic ultrasound-guided biliary drainage.
Scientific Title
Impact of non-dilation techniques and other clinical and procedural factors on the outcomes of endoscopic ultrasound-guided biliary drainage.
Scientific Title:Acronym
Impact of non-dilation techniques and other clinical and procedural factors on the outcomes of endoscopic ultrasound-guided biliary drainage.
Region
| Japan |
Condition
Condition
Biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to retrospectively investigate the impact of stent selection, patient characteristics, and procedural factors, including the use of non-dilation techniques, on the clinical outcomes of endoscopic ultrasound-guided biliary drainage (EUS-BD), and to identify optimal procedural and perioperative management strategies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of procedure-related adverse events
Key secondary outcomes
Clinical success, length of hospital stay, procedure time, recurrent biliary obstruction (RBO) and time to recurrent biliary obstruction (TRBO)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent EUS-guided biliary drainage (EUS-BD) with EUS-guided hepaticogastrostomy (EUS-HGS) or EUS-guided hepaticojejunostomy (EUS-HJS) between January 1, 2019, and January 26, 2026.
Key exclusion criteria
Repeated EUS-BD procedures in the same patient (only the first procedure included), EUS-BD procedures other than EUS-HGS/HJS, cases with unavailable data on preprocedural infection status or antibiotic use, and cases deemed inappropriate by the investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Faculty of Medicine, Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita, Japan
TEL
097-586-6193
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Faculty of Medicine, Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita, Japan
TEL
097-586-6193
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita University Faculty of Medicine Ethics Committee
Address
1-1, idaigaoka, Hasama, Yufu, Oita, Japan
Tel
097-586-5157
rinrikenkyu@oita-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071229
